Drugs List

Therapeutic Indications

Uses

Eye - non-infected inflammatory conditions

Contraindications

Children under 2 years
Soft contact lenses
Breastfeeding
Ocular infection
Pregnancy
Undiagnosed red eye

Precautions and Warnings

Glaucoma
History of herpes simplex keratitis

May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Check ocular lens frequently - risk of cataract formation
Monitor intraocular pressure frequently - risk of steroid glaucoma
Prolonged use may cause raised intraocular pressure
Prolonged use may result in ocular infections
Maximum duration of treatment is 7 days unless on specialist advice
Advise patient to avoid touching the eye/other surfaces with container tip
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

The manufacture notes that fluormetholone is not recommended in pregnancy.

Fluorometholone is, as are other corticosteroids, teratogenic in animals.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The manufacture notes that fluormetholone is not recommended in breastfeeding.

It is unknown whether fluorometholone is excreted in human milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Blurred vision
Cataracts
Conjunctival hyperaemia
Dysgeusia
Eye infection
Eye pain
Eye pruritus
Eyelid oedema
Glaucoma
Hypersensitivity reactions
Increased intra-ocular pressure
Increased lacrimation
Mydriasis
Ocular discharge
Ocular hyperaemia
Ocular irritation
Ocular oedema
Punctate keratitis
Rash
Sensation of foreign body in eye
Subcapsular cataract
Ulcerative keratitis
Visual disturbances
Visual field defects

Presentation

Eye drops containing fluorometholone

Drugs List

Therapeutic Indications

Uses

Eye - non-infected inflammatory conditions

Dosage

Adults

Elderly

Children

Contraindications

Children under 2 years
Soft contact lenses
Breastfeeding
Ocular infection
Pregnancy
Undiagnosed red eye

Precautions and Warnings

Glaucoma
History of herpes simplex keratitis

May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Check ocular lens frequently - risk of cataract formation
Monitor intraocular pressure frequently - risk of steroid glaucoma
Prolonged use may cause raised intraocular pressure
Prolonged use may result in ocular infections
Maximum duration of treatment is 7 days unless on specialist advice
Advise patient to avoid touching the eye/other surfaces with container tip
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

The manufacture notes that fluormetholone is not recommended in pregnancy.

Fluorometholone is, as are other corticosteroids, teratogenic in animals.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The manufacture notes that fluormetholone is not recommended in breastfeeding.

It is unknown whether fluorometholone is excreted in human milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Blurred vision
Cataracts
Conjunctival hyperaemia
Dysgeusia
Eye infection
Eye pain
Eye pruritus
Eyelid oedema
Glaucoma
Hypersensitivity reactions
Increased intra-ocular pressure
Increased lacrimation
Mydriasis
Ocular discharge
Ocular hyperaemia
Ocular irritation
Ocular oedema
Punctate keratitis
Rash
Sensation of foreign body in eye
Subcapsular cataract
Ulcerative keratitis
Visual disturbances
Visual field defects

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2013

Reference Sources

Joint Formulary Committee. British National Formulary. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013.

Paediatric Formulary Committee. BNF for Children 2013-2014. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2013.

Summary of Product Characteristics: FML. Allergan Ltd. Revised September 2013.